A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers

February 4, 2022 updated by: Corcept Therapeutics

A 4-week, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers

This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers to determine the average change in absolute weight at Day 28 compared to baseline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers. The primary study objective is to determine the mean change in absolute weight at Day 28 compared to baseline in normal healthy male volunteers treated with risperidone plus mifepristone or risperidone alone. The secondary study objectives are to determine the mean percent change in baseline body weight; and the proportion of subjects that gain less than 5% and less than 7% of their baseline body in the treatment groups.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Mumbai, India
        • Dhirubhai Ambani Life Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • BMI ≥ 18 and ≤ 23 kg/m2
  • Able to provide written informed consent
  • Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits
  • AST, ALT, Tbili within normal limits at screening
  • Medical and psychiatric history and physical examination devoid of any significant findings that would interfere with participation or interpretation of results in this study
  • Agree to use a barrier method of birth control for 28 days following the last dose of study medication
  • Have maintained a stable weight for at least 6 months prior to Screening

Exclusion Criteria:

  • Prior or current history of any psychiatric disorder, including eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder
  • Positive urine drug screen for any drug of abuse (including amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines) unless prescribed by a physician
  • Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing
  • Have a history of an allergic reaction to either mifepristone or risperidone
  • Any other clinically significant abnormality on screening laboratory tests
  • QTc Bazzett's ≥ 450 msec
  • History of or current major medical condition, which in the opinion of the Investigator would place the patient at undue risk.
  • Receiving any prescription or over-the-counter medications that could potentially affect appetite or weight
  • Any history of a movement disorder such as Tardive Dyskinesia, Parkinsonism
  • Any personal or family history of Neuroleptic Malignant Syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Risperidone plus mifepristone
risperidone plus mifepristone daily for 28 days
Drug: Risperidone
risperidone daily for 28 days
Other Names:
  • Risperdal
Drug: Mifepristone
mifepristone daily for 28 days
Other Names:
  • Corlux
PLACEBO_COMPARATOR: Risperidone plus mifepristone-matched placebo
risperidone plus mifepristone-matched placebo daily for 28 days
Drug: Risperidone
risperidone daily for 28 days
Other Names:
  • Risperdal
Drug: Mifepristone-matched placebo
mifepristone-matched placebo daily for 28 days
PLACEBO_COMPARATOR: Risperidone-matched placebo plus mifepristone
risperidone-matched placebo plus mifepristone daily for 28 days
Drug: Mifepristone
mifepristone daily for 28 days
Other Names:
  • Corlux
Drug: Risperidone-matched placebo
risperidone-matched placebo daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Body Weight
Time Frame: Baseline and 28 days
Baseline and 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight
Time Frame: Baseline and 28 days
Baseline and 28 days
Percentage of Participants With One or More Adverse Events
Time Frame: Up to 28 days
Up to 28 days
Percentage of Participants Discontinued From the Study Due to an Adverse Event
Time Frame: Up to 28 days
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corcept Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

February 1, 2009

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (ESTIMATE)

June 16, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 4, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-1073-205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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